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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IPERIA 7 HF-T DF4 PROMRI; CRT-D
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BIOTRONIK SE & CO. KG IPERIA 7 HF-T DF4 PROMRI; CRT-D Back to Search Results
Model Number 393009
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/19/2018
Event Type  Injury  
Event Description
This system was explanted due to infection.New system was not implanted.Should additional information become available, this file will be updated.
 
Manufacturer Narrative
An infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the infection was not device related.
 
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Brand Name
IPERIA 7 HF-T DF4 PROMRI
Type of Device
CRT-D
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM  D-12359
MDR Report Key8191215
MDR Text Key131208288
Report Number1028232-2018-04361
Device Sequence Number1
Product Code NIK
UDI-Device Identifier04035479129255
UDI-Public(01)04035479129255
Combination Product (y/n)N
PMA/PMN Number
P050023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number393009
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age54 YR
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